Centre for Rare Lung Disease, University of Modena and Reggio Emilia, Modena, Italy.
Respir Res. 2013;14 Suppl 1(Suppl 1):S4. doi: 10.1186/1465-9921-14-S1-S4. Epub 2013 Apr 16.
The magnitude of treatment effect can be assessed by a number of methods. One reliable method of collectively analysing data from randomised clinical trials is that used in Cochrane reviews. These systematic reviews identify and analyse the available evidence using the reliable method of meta-analysis. These often combine data from studies to provide robust evaluations of overall treatment effects. In 2003, a review of data from studies of corticosteroid use in IPF patients found no evidence of a treatment effect. Similarly, very little evidence was found to support the use of immunomodulatory agents. A recent update of these Cochrane reviews failed to identify any new evidence supporting the use of corticosteroids in IPF. However, a review of non-steroid agents for the treatment of IPF identified data from 15 RCTs that was suitable for analysis. Two trials of interferon gamma-1b were pooled and analysed, but no treatment effect was observed in terms of survival. Meta-analysis of three Phase III studies of pirfenidone treatment in IPF patients suggested that progression-free survival was significantly increased by 30%, demonstrating a reduction in the decline of lung function in IPF patients. In addition, there are numerous ongoing trials investigating potential therapeutic agents which provides hope for IPF patients and their doctors.
治疗效果的大小可以通过多种方法进行评估。一种可靠的方法是在 Cochrane 综述中使用荟萃分析来综合分析随机临床试验的数据。这些系统评价使用可靠的荟萃分析方法识别和分析现有证据。这些方法通常可以综合研究数据,为整体治疗效果提供有力的评估。2003 年,一项关于 IPF 患者使用皮质类固醇治疗的数据综述发现,皮质类固醇治疗没有效果。同样,几乎没有证据支持免疫调节剂的使用。最近对这些 Cochrane 综述的更新没有发现任何新的证据支持在 IPF 中使用皮质类固醇。然而,对非甾体类药物治疗 IPF 的综述确定了 15 项 RCT 的数据,这些数据适合进行分析。对两种干扰素 γ-1b 的试验进行了汇总和分析,但在生存方面没有观察到治疗效果。对 3 项 III 期吡非尼酮治疗 IPF 患者的研究进行荟萃分析表明,无进展生存率显著提高了 30%,表明 IPF 患者的肺功能下降速度减缓。此外,还有许多正在进行的试验研究潜在的治疗药物,这为 IPF 患者及其医生带来了希望。